An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
18 Years
N/A
Male
Prostate Cancer
Trial Information
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Inclusion Criteria
Inclusion/Exclusion Criteria:
- Patients with histologically proven prostate cancer of all stages in whom endocrine
treatment is indicated.
- Signed informed consent
- The patients must have completed the FE 200486 CS21 Study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Outcome Description:
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
Outcome Time Frame:
Up to 4 years of treatment
Safety Issue:
No
Principal Investigator
Clinical Development Support
Investigator Role:
Study Director
Investigator Affiliation:
Ferring Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
FE200486 CS21A
NCT ID:
NCT00451958
Start Date:
March 2007
Completion Date:
December 2011
Related Keywords:
- Prostate Cancer
- Degarelix
- prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Urology San Antonio Research | San Antonio, Texas 78229 |
| South Florida Medical Research | Aventura, Florida 33180 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| Regional Urology | Shreveport, Louisiana 71106 |
| South Orange County Medical Research Center | Laguna Hills, California 92653 |
| Lawrenceville Urology | Lawrenceville, New Jersey 08648 |
| Western Clinical Research | Torrance, California 90505 |
| State College Urologic Association | State College, Pennsylvania 16801 |
| Investigational Site | Durham, North Carolina 27710 |
| Investigational Site | New York, New York 10032 |
| Urology Associates Research | Englewood, Colorado |
| Investigational Site | Ocala, Florida |
| North Urology Research | Concord, North Carolina |
| Seattle Urology Research Center | Burien, Washington |
